By Gisela Leon, MS, MBA, Independent EAS Consultant
On November 22, FDA published 15 warning letters in a “catch all” effort regarding cannabidiol products. The products range from articles sold as dietary supplements, conventional foods, cosmetics, and animal food. FDA sent out the 15 warning letters to companies in a number of states, including California, Texas, Oklahoma, Colorado, Oregon, New York, Florida, North Carolina, Arizona, and Kentucky based on the content of websites and social media sites. This was not the first time FDA had sent warning letters regarding cannabidiol [CBD]. The first seven CBD warning letters were issued in March 2019.
In the warning letters for dietary supplement products, FDA states that CBD in products sold as dietary supplements does not meet the definition of dietary ingredients in the Federal Food, Drug, and Cosmetic Act (321(ff)(B)(i)(ii)). This provision clarifies that a dietary ingredient cannot be a substance that has been approved as an active ingredient in a drug. FDA has confirmed that CBD is an active ingredient in the approved drug Epidiolex.
FDA has also indicated that it cannot conclude CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food because of gaps in the safety data. Some of the data that exists has raised concerns that CBD is potentially harmful and may cause liver damage or interact with other drugs. Furthermore, studies in animals has shown that CBD may impair sexual behavior in males.
Similarly, FDA states in relevant warning letters that CBD is an unapproved new animal drug because of disease claims. The products are also adulterated animal foods because there is no animal food additive regulation that authorizes the use of CBD and there is no basis to conclude that CBD is GRAS for use in animal foods.
In addition to the lack of regulatory status for CBD as a dietary ingredient or food additive, cosmetics, conventional foods and dietary supplements that received Warning Letters are regarded as unapproved new drugs, because of product and websites claims that CBD is intended to cure, mitigate, treat, or even prevent diseases. The manufacturers that received the warning letters cited numerous diseases for which CBD might be helpful. Some of the popular disease claims involve pain relief, anti-inflammatory, diabetes, acne, anxiety, depression and cancer. For example, one Warning Letter cites 45 diseases.
Most warning letters were signed by three FDA compliance directors from Center for Drug Evaluation and Research, Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition. In some of the earlier warning letters FDA also involved FTC – Federal Trade Commission – because of unsubstantiated claims. Both agencies are concerned that some of the efficacy claims may not be substantiated by competent and reliable scientific evidence.
At present, it appears that FDA is only taking enforcement action against CBD products with disease claims. To date, FDA has not written a warning letter solely because a dietary supplement or conventional food contains CBD. These most recent warning letters could have been written to any dietary supplement making disease claims.
Trade associations have petitioned FDA to issueenforcement discretion r that would allow manufacturers to legally market dietary supplements containing CBD. Senate Majority Leader Mitch McConnell introduced language in the Senate Agriculture Appropriation bill that would require FDA to temporarily adopt an enforcement discretion policy in 120 days. The FDA would still be able to take enforcement actions against companies who make disease claims, similar to the recent warning letters.
So, what can be learned from FDA’s actions? The first and most important step for manufacturers would be to “clear” all webpages, social media pages, and third-party referrals of disease statements. As a regulatory strategy, this may buy some time until the controversy about the legality of use in foods and dietary supplements is clarified. For dietary supplements a possible alternative legal ingredient is a full spectrum hemp extract which contains all hemp components – not just isolated CBD. Hemp-derived ingredients are eligible for use as dietary ingredients by virtue of being “botanicals”. However, hemp derived substances must submit a New Dietary Ingredient notification 75-days prior to first marketing the hemp supplement. A less conservative regulatory approach for dietary supplements could be to wait and see if the Senate Agriculture Appropriations bill passes with the CBD language intact which requires FDA to adopt a temporary enforcement policy.